FDA.reportPublic FDA data

Implantable craniofacial bone distractor

Definition
An implantable or partially-implantable device intended to temporarily distract (force apart) the two bone surfaces of the mandible (the lower jawbone) or maxilla (the upper jawbone) during craniomaxillofacial (CMF) distraction. It functions as a single-patient bone lengthening/augmentation device for the correction of congenital deficiencies or post-traumatic defects when gradual bone augmentation is required. It typically consists of a metal tube in which a right- and left-hand threaded rod rotates and to which are attached two craniofacial fixation plates that are surgically screwed to either side of the fracture. A small tip guard may be included to protect against inadvertent rotation.
GUDID devices
1,207
Last updated
2025-03-04 15:09:27

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00888118143457DISTRACTION, INTERNALKLS-Martin L.P.51-362-20-092025-02-24
00888118139962DISTRACTION, INTERNALKLS-Martin L.P.51-401-60-052023-02-23
00888118136428DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.51-412-23-712022-10-04
00888118136435DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.51-412-33-712022-10-04
00888118136442DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.51-412-43-712022-10-04
00888118136459DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.51-412-53-712022-10-04
00888118136466DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.51-402-30-712022-10-04
00888118136473DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.51-402-40-712022-10-04
00888118136480DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.51-402-50-712022-10-04
00888118136497DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.51-401-60-712022-10-04
00888118136503DISTRACTION, INTERNALKLS-Martin L.P.51-412-23-052022-10-04
00888118136510DISTRACTION, INTERNALKLS-Martin L.P.51-412-33-052022-10-04
00888118136527DISTRACTION, INTERNALKLS-Martin L.P.51-412-43-052022-10-04
00888118136534DISTRACTION, INTERNALKLS-Martin L.P.51-412-53-052022-10-04
00888118136541DISTRACTION, INTERNALKLS-Martin L.P.51-402-30-052022-10-04
00888118136558DISTRACTION, INTERNALKLS-Martin L.P.51-402-40-052022-10-04
00888118136565DISTRACTION, INTERNALKLS-Martin L.P.51-402-50-052022-10-04
00888118136572DISTRACTION, INTERNALKLS-Martin L.P.51-401-60-092022-10-04
00888118127907DISTRACTION, INTERNALKLS-Martin L.P.51-525-21-092022-05-23
00888118127914DISTRACTION, INTERNALKLS-Martin L.P.51-525-22-092022-05-23
00888118129581DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.51-351-20-712021-10-22
00888118128690DISTRACTION, INTERNALKLS-Martin L.P.51-424-25-912021-08-20
00888118128737DISTRACTION, INTERNALKLS-Martin L.P.51-424-30-912021-08-20
00888118129956DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.51-432-30-712021-06-16
00888118129895DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.51-360-40-712021-05-21
00888118129901DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.51-361-40-712021-05-21
00888118129062DISTRACTION, INTERNALKLS-Martin L.P.51-351-21-092021-03-23
00888118129079DISTRACTION, INTERNALKLS-Martin L.P.51-351-22-092021-03-23
00888118129413DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.02-406-40-712021-02-22
00888118129420DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.51-410-23-712021-02-22
00888118127754DISTRACTION, INTERNALKLS-Martin L.P.51-443-30-092020-12-22
00888118129109DISTRACTION, INTERNALKLS-Martin L.P.51-410-23-092020-12-22
00888118129116DISTRACTION, EXTERNALKLS-Martin L.P.51-582-63-092020-12-22
00888118129123DISTRACTION, EXTERNALKLS-Martin L.P.51-580-46-042020-12-22
00888118129130DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.51-401-13-712020-12-22
00888118129147DISTRACTION, INTERNALKLS-Martin L.P.51-401-09-092020-12-22
00888118129154DISTRACTION, INTERNALKLS-Martin L.P.51-401-06-092020-12-22
00888118129161DISTRACTION, INTERNALKLS-Martin L.P.51-401-03-092020-12-22
00888118129178DISTRACTION, INTERNALKLS-Martin L.P.51-402-70-092020-12-22
00888118129185DISTRACTION, INTERNALKLS-Martin L.P.51-402-71-092020-12-22
00888118129192DISTRACTION, INTERNALKLS-Martin L.P.51-402-72-092020-12-22
00888118129208DISTRACTION, INTERNALKLS-Martin L.P.51-402-73-092020-12-22
00888118129215DISTRACTION, EXTERNALKLS-Martin L.P.51-582-64-092020-12-22
00888118129222DISTRACTION, EXTERNALKLS-Martin L.P.51-582-65-092020-12-22
00888118128836DISTRACTION, EXTERNALKLS-Martin L.P.51-582-61-092020-10-22
07613327504408NAStryker Leibinger GmbH & Co. KG92-023232020-05-12
07613327504415NAStryker Leibinger GmbH & Co. KG92-023222020-05-12
04046826323295MediconMedicon eG. Chirurgiemechaniker-Genossenschaft69.00.302020-09-24
00888118127785DISTRACTION, INTERNALKLS-Martin L.P.51-406-43-092020-09-21
00888118127792DISTRACTION, INTERNALKLS-Martin L.P.51-542-05-092020-09-21
00888118127808DISTRACTION, INTERNALKLS-Martin L.P.51-542-15-092020-09-21
00888118127815DISTRACTION, INTERNALKLS-Martin L.P.51-427-02-092020-09-21
00888118127822DISTRACTION, INTERNALKLS-Martin L.P.51-427-12-092020-09-21
00888118127891DISTRACTION, INTERNALKLS-Martin L.P.51-406-33-092020-09-21
00888118127723DISTRACTION, EXTERNALKLS-Martin L.P.51-601-95-092020-08-24
00888118127730DISTRACTION, INTERNALKLS-Martin L.P.51-424-32-092020-08-24
00888118127747DISTRACTION, INTERNALKLS-Martin L.P.51-424-33-092020-08-24
00888118127839DISTRACTION, INTERNALKLS-Martin L.P.51-362-30-092020-08-24
00888118127846DISTRACTION, INTERNALKLS-Martin L.P.51-401-17-092020-08-24
00888118127853DISTRACTION, INTERNALKLS-Martin L.P.51-401-21-092020-08-24
00888118127860DISTRACTION, INTERNALKLS-Martin L.P.51-401-12-092020-08-24
00888118127877DISTRACTION, INTERNALKLS-Martin L.P.51-406-31-092020-08-24
00888118127884DISTRACTION, INTERNALKLS-Martin L.P.51-406-32-092020-08-24
00888118128515DISTRACTION, INTERNALKLS-Martin L.P.51-432-30-092020-08-24
00888118127761DISTRACTION, INTERNALKLS-Martin L.P.51-360-40-092020-07-22
00888118127778DISTRACTION, INTERNALKLS-Martin L.P.51-361-40-092020-07-22
00842528123300OsteoMedOSTEOMED LLC218-3190-SP2019-11-08
00842528123317OsteoMedOSTEOMED LLC218-3195-SP2019-11-08
00841036010607N/ABIOMET MICROFIXATION, INC01-32712015-10-11
00841036010614N/ABIOMET MICROFIXATION, INC01-32722015-10-11
00841036010652DISTRACTION SYSTEMBIOMET MICROFIXATION, INC01-33202015-10-11
00841036010669DISTRACTION SYSTEMBIOMET MICROFIXATION, INC01-33242015-10-11
00841036010676DISTRACTION SYSTEMBIOMET MICROFIXATION, INC01-33282015-10-11
00841036010683DISTRACTION SYSTEMBIOMET MICROFIXATION, INC01-33302015-10-11
00841036010690DISTRACTION SYSTEMBIOMET MICROFIXATION, INC01-33342015-10-11
00841036010836EXTERNAL DISTRACTIONBIOMET MICROFIXATION, INC01-35502015-10-11
00841036010843EXTERNAL DISTRACTION SYSTEMBIOMET MICROFIXATION, INC01-35512015-10-11
00841036010850EXTERNAL DISTRACTION SYSTEMBIOMET MICROFIXATION, INC01-35522015-10-11
00841036010904EXTERNAL DISTRACTION SYSTEMBIOMET MICROFIXATION, INC01-35802015-10-11
00841036010911EXTERNAL DISTRACTION SYSTEMBIOMET MICROFIXATION, INC01-35842015-10-11